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numed mullins pta catheter
Numed
Summary: The Numed Mullins PTA Catheter is a medical device used for percutaneous transluminal angioplasty (PTA) procedures. It is primarily utilized by interventional cardiologists and radiologists to treat venous stenosis.
FDA Clearance Information
Pathway
510K
Number
K013601 ↗
Decision Date
January 3, 2002
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Numed Mullins PTA Catheter was cleared through the FDA 510(k) pathway on January 3, 2002. Manufactured by Numed, it is classified as a Class 2 device under product code DQY.
What It Is
The Numed Mullins PTA Catheter is a specialized balloon catheter designed for use in percutaneous transluminal angioplasty. It works by inflating a balloon at the site of a vessel stenosis to widen the vessel and improve blood flow. This device is particularly useful in treating venous stenosis, where narrowing of the veins can impede circulation.
Clinical Applications
This catheter is commonly used in interventional cardiology and radiology settings for procedures involving the dilation of narrowed venous pathways. It is particularly relevant in the treatment of conditions such as venous stenosis in patients with vascular access issues, such as those undergoing dialysis. The device is typically used in hospital settings by specialists trained in endovascular procedures.
Indications for Use
The FDA indications for the Numed Mullins PTA Catheter involve its use in procedures aimed at dilating narrowed veins. This is particularly applicable for patients with conditions that lead to venous stenosis, which can cause complications in blood flow.
Practical Considerations
The Numed Mullins PTA Catheter comes in various sizes to accommodate different vessel diameters and patient needs. It is compatible with standard guidewires and requires careful handling to ensure precise placement and inflation during procedures.
Frequently Asked Questions
What is the Numed Mullins PTA Catheter used for?
It is used for percutaneous transluminal angioplasty to treat venous stenosis by dilating narrowed veins.
What specialties typically use this device?
Interventional cardiologists and radiologists typically use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for use in procedures to dilate narrowed veins, particularly in cases of venous stenosis.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.